Health TrialsbyHealthPanel

Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt

ConditionGLAUCOMA 1, OPEN ANGLE, D (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the XEN®-63 Gel Stent in reducing IOP after surgery. 

The main questions it aims to answer are:

* Does the PRESERFLO™ MicroShunt provide IOP reduction at 12 months that is non-inferior to the XEN®-63 Gel Stent? * How do the two devices compare over 24 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures?

Participants will:

* Be randomly assigned (1:1) to receive either the XEN®-63 Gel Stent or the PRESERFLO™ MicroShunt during a single glaucoma surgery. * Attend scheduled follow-up visits over 24 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments. * Receive standard postoperative care and report any complications or additional treatments during the study period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>40 years of age

An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEX)

Inadequately controlled on maximum tolerated medical therapy.

Mean Deviation (MD) </= -3

Disqualifiers

An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX)

Lens status: Aphakic patients or Anterior chamber intraocular lens

Previous procedures: Glaucoma shunt/valve/ surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months.

Presence of intraocular silicone oil

Trial design

Design model

Parallel

Treatments tested in this trial

  • XEN®-63 Gel Stent

    Device

    The XEN®-63 Gel Stent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.

  • PRESERFLO™ MicroShunt

    Device

    The PRESERFLO™ MicroShunt is a SIBS-polymer microshunt. This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: PRESERFLO MicroShuntExperimental treatment 1 intervention
Group B: XEN 63 GelstentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraocular pressure

Time frame
1 year

Secondary outcomes

1

Number of medications

Number of topical glaucoma medications

Time frame
2 year
2

adverse events

Time frame
2 years
3

secundary pressure-lowering surgery

Time frame
2 years
4

Mean Deviation changes on the visual field

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

University Hospital, Bonn

Collaborator

Hospital de Santa Maria, Lisbon

Collaborator

Source ClinicalTrials.gov
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